Baxter recalls Sigma Spectrum Infusion Pumps (Version 6) with serial numbers starting 709860-1017627 due to missing air-in-line and occlusion detection tests, which could cause serious health issues.
Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr and verification of upstream occlusion detection at 800ml/hr. Improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences.
Baxter is recalling certain Sigma Spectrum Infusion Pumps (Version 6) because service technicians improperly documented testing, missing critical safety checks. This could lead to serious health problems if air or blockages in the tubing are not detected properly.
The pump's safety checks for air in the tubing and blockages were not properly completed during testing. If these checks fail, the pump might not detect air or blockages, which could cause serious health issues like incorrect medication delivery or blood clots.
Healthcare professionals using Baxter Sigma Spectrum Infusion Pumps with master Drug Library (Version 6) and serial numbers listed in the recall are affected. Patients receiving treatments through these pumps are at risk if the device fails to detect air or blockages.
Check for serial numbers starting with 709860 through 1017627 on the pump's label. These pumps were sold with the master Drug Library (Version 6) software.
Look for the serial number on the pump's label to confirm if it's in the list of affected units (709860 to 1017627).
Reach out to Baxter Healthcare Corporation for guidance on next steps if you have an affected pump.
The pump's safety tests for air in the tubing and blockages were not properly completed during testing, which could lead to serious health issues if the device fails to detect these problems.
Check the serial number to see if it's in the list of affected units (709860 to 1017627). If so, contact Baxter Healthcare Corporation for guidance.
The recall record does not specify a fix; it only mentions that affected pumps should be checked and contacted for guidance.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-1664-2018 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-1664-2018 from Baxter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
